PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-07-31

Brief Summary

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Using methods of molecular biology bacteria can be detected in blood. In comparison to conventional blood cultures "bacterial DNA" is isolated using a new sample preparation system in platelet apheresis concentrates and in the predonation whole blood of donors.

Detailed Description

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Bacterial contamination of platelet concentrates is discussed worldwide and according to literature occuring in 1:1000 to 1:5000 concentrates. Bacterial contaminated concentrates can in fact cause severe infections in patients. therefore this study initially intends to detect contamination with "bacterial DNA" in platelet aphereses concentrates. All sample donations are also examined by blood culture for contamination. To exclude already existing "infection" of the donor one tube of whole blood is taken in addition to the other legally required samples for the production of pharmaceutical medicine. All samples are anonymised before passed on for analysing.

Conditions

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Healthy

Study Design

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Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy platelet apheresis donor

Exclusion Criteria

* Missing health clearance for blood donation

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Dagmar Barz, Prof Dr med.

Role: STUDY_DIRECTOR

University Hospital Jena, Germany

Locations

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Institute for Transfusion Medicine, University Hospital Jena

Jena, Thuringia, Germany

Site Status

Countries

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Germany

Facility Contacts

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Thomas Lorenzen, Dr. med.

Role: primary

[email protected]

+49 3641 935475

Silke Rummler, Dr. med.

Role: backup